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FDA 510(k)

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures

K-Number: K191483 · 2019-06-28

ApplicantMedos International SARL
Decision Date2019-06-28
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2019-06-28 under approval number K191483. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Medos International SARL. The 510(k) number is K191483.

When was HEALIX ADVANCE Anchor with DYNA+TAPE Sutures approved by the FDA?

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures received FDA 510(k) clearance on 2019-06-28, under approval number K191483.

What company makes HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is manufactured by Medos International SARL.

What is the FDA product code for HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

The FDA product code for HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is MBI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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